Surface modified surgical instruments, devices, implants, contact lenses and the like

• US 4,961,954 A
• Filed: 02/01/1989
• Issued: 10/09/1990
• Est. Priority Date: 04/10/1987
• Status: Expired due to Fees

• Current Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: University of Florida (State University System of Florida)
• Inventors: Burns, James W., Sheets, John W., Larson, Jeffrey A., Osborn, David C., Robinson, Richard, Yahiaoui, Ali, Goldberg, Eugene P., Kumar, G. Sudesh
• Primary Examiner(s): LUSIGNAN, MICHAEL R
• Application Number:
  US07/304,479
• Time in Patent Office: 615 Days
• Field of Search: 427/2, 427/36, 522/84, 522/85, 522/167, 623/4, 623/5, 623/6, 623/1, 623/3, 623/66, 604/96, 606/107
• US Class Current: 600/36
• CPC Class Codes: A61F 2/16 Intraocular lenses
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: C08J 7/18 using wave energy or particle radiation
• CPC Class Codes: C08L 51/06 grafted on to homopolymers or copolymers of aliphatic hydrocarbons containing only one carbon-to-carbon double bond
• CPC Class Codes: G02C 7/02 Lenses; Lens systems ; Methods of designing lenses
• CPC Class Codes: Y10S 623/921 Blood vessel
• CPC Class Codes: Y10T 428/265 1 mil or less
• CPC Class Codes: Y10T 428/31507 Of polycarbonate
• CPC Class Codes: Y10T 428/31544 Addition polymer is perhalogenated
• CPC Class Codes: Y10T 428/31663 As siloxane, silicone or silane

Abstract

Improved medical devices and instruments prepared by an improved method of producing hydrophilic, gamma irradiation induced polymerized and chemically grafted coatings or plastic surfaces of articles adapted for contacting living tissue, the improvement comprising carrying out the graft polymerization in an aqueous solution under specific combinations of the following conditions:

(1) monomer concentration in the range of from about 0.5% to about 50%, by weight;

(2) total gamma dose in the range of from about 0.01 to less than about 0.50 Mrad;

(3) gamma dose rate in the range of from about 10 to about 2500 rads/min; and

(4) maintaining the molecular weight of the polymer in solution in the range of from about 250,000 to about 5,000,000.

Claims

1. In a method for modifying a plastic surface of an article, said surface adapted for contact with living tissue of a human or non-human animal by the gamma-irradiation induced polymerized, chemically grafted coating thereon of a monomer comprising N-vinylpyrrolidone (NVP), 2-hydroxyethylmethacrylate (HEMA) or a mixture of (NVP) and (HEMA) so as to form a thin, hydrophilic coating of (1) poly-N-vinylpyrrolidone (PVP), (2) poly-2-hydroxyethylmethacrylate (PHEMA), or (3) a copolymer of NVP and HEMA [P(NVP-HEMA)] on said surface, the improvement comprising:

conducting said gamma-irradiation induced graft polymerization in an aqueous solution under the following conditions;

(1) monomer concentration in the range of from about 0.5% to about 50%, by weight;

(2) total gamma dose in the range of from about 0.01 to less than about 0.50 Mrad;

(3) gamma dose rate in the range of from about 10 to about 2500 rads/min; and

(4) maintaining the molecular weight of the polymer in solution in the range of from about 250,000 to about 5,000,000.

2. The method of claim 1 further including one or more of the following conditions:

(5) substantially excluding free oxygen from said graft polymerization solution;

(6) maintaining the thickness of said polymer coating in the range of from about 100 Å

to about 100 microns;

(7) including a free radical scavenger in said aqueous graft polymerization solution; and

(8) including in said aqueous graft polymerization solution a swelling solvent for said PMMA surface.

3. The method of claim 1 wherein said article is a surgical instrument.

4. The method of claim 1 wherein said article is a medical device.

5. The method of claim 1 wherein said article is a prosthetic implant.

6. The method of claim 1 wherein said article is a soft or hard contact lens.

7. The method of claim 1 wherein said NVP, HEMA or mixture of NAP and HEMA is gamma-irradiation induced co-polymerized with an ionic monomer or mixture thereof under said conditions, the total monomer concentration in said solution being in the range of from about 1% to about 50%, by weight, and maintaining the molecular weight of the resultant copolymer in solution of NVP, HEMA or mixture of NVP and HEMA and said ionic monomer or mixture thereof in the range of from about 250,000 to about 5,000,000.

8. The method of claim 7 wherein said ionic monomer is a vinylsulfonic acid or a vinylcarboxylic acid.

9. The method of claim 8 wherein said vinylcarboxylic acid is acrylic, methacrylic or crotonic acid.

10. The method of claim 7 wherein said ionic monomer is an amino-functional monomer.

11. The method of claim 10 wherein said aminofunctional monomer is a vinylpyridine, an aminostyrene, an aminoacrylate or an aminomethacrylate.

12. An article prepared according to the method of claim 1.

13. An article according to claim 12 comprising a surgical instrument, medical device, prosthetic implant or contact lens.